FDA Inspection 826331 — California Cryobank LLC d.b.a. Cooper Surgical
The FDA completed an inspection of California Cryobank LLC d.b.a. Cooper Surgical on April 12, 2013 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |